Affirm Breast Biopsy Guidance System
FDA 510(k) K103512 · Hologic, Inc.
510(k) numberK103512
Submission
- Device name
- Affirm Breast Biopsy Guidance System
- Applicant
- Hologic, Inc.
Danbury, CT, US - Received
- November 30, 2010
- Decision date
- January 7, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K203509 | Smart FinderIZH · Special | Ims Giotto S.P.A. | 07/14/2021SE |
| K202294 | Affirm Contrast BiopsyIZH · Special | Hologic, Inc. | 10/05/2020SE |
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| K161920 | Comfort CoverIZH · Traditional | Precision Dynamics Corporation | 07/15/2016SE |
| K153486 | Affirm Prone Biopsy SystemIZH · Traditional | Hologic, Inc. | 04/01/2016SE |
| K152038 | MammoGRIPIZH · Traditional | Women'S Imaging Solutions Enterprises, LLC | 12/22/2015SE |
| K123414 | Specboard Jr.IZH · Traditional | Macbrud Corp., Medical Division | 01/11/2013SE |
| K122836 | Affirm Breast Biopsy Guidance SystemIZH · Special | Lorad, A Hologic Co. | 01/11/2013SE |
| K113607 | Biopsy Digit S Biopsy SLIZH · Traditional | Giotto USA, LLC | 08/10/2012SE |
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Questions and answers
When was Affirm Breast Biopsy Guidance System cleared by the FDA?
Affirm Breast Biopsy Guidance System (K103512) received a 510(k) decision of Substantially Equivalent on January 7, 2011, 38 days after the submission was received.
What is the product code of K103512?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.